The Importance of Import Risk Analysis in Protecting Animal Health
Over the past year, the Food Safety Network has partnered with Animal and Plant Health Inspection Service (APHIS) Veterinary Services to develop an online learning module covering topics related to animal health and emergency preparedness and response. To commemorate this work, the Food Safety Network is releasing a series of blogs focused on select topics discussed within this online learning module. This blog is the third in a six-part series and focuses on the topic of Import Risk Analysis in Protecting Animal Health.
The World Trade Organization (WTO) is the international organization that establishes the global rules of trade between nations. It provides a set of guiding principles to address the needs and challenges associated with international trade and market liberalization. The WTO binds member governments to keep their trade policies within established limits to ensure that trade flows as smoothly, predictably and freely as possible.
After being established, one of the first major tasks taken on by the WTO was to address non-tariff trade barriers and agricultural trade through the development of the Agreement on the Application of Sanitary and Phytosanitary Measures, or the SPS Agreement. "The SPS agreement aimed to achieve a balance between free trade and the protection of human, animal and plant life by seeking a more consistent and formal approach to the assessment of disease risks associated with trade." Per the agreement, SPS measures should be based on internationally agreed upon guidelines and recommendations, as well as being scientifically justified and based on an assessment of risk.
Member countries must be certain that the SPS measures they apply are based on risk analysis methods. The risk analysis should take into consideration methods developed by international standard setting organizations. For animal health, the international standard setting organization is the World Organization for Animal Health (OIE).
The OIE is the intergovernmental organization responsible for improving animal health (for both terrestrial and aquatic animals) worldwide. The OIE’s mission areas are transparency, scientific information, international solidarity, sanitary safety, promotion of veterinary services and food safety and animal welfare.
The importation of animal commodities — both live animals and their products — presents a certain level of risk to the importing country for the introduction of diseases, infections and infestations. The importing country has the right to implement sanitary measures to protect animal health; however, the measures must be necessary, science-based, and non-discriminatory. In order to understand the risks associated with the importation of animal commodities from an exporting country and to justify sanitary measures, the importing country conducts an import risk analysis.
What is an import risk analysis?
There are four main components of an import risk analysis:
- Risk assessment.
- Risk management.
- Risk communication.
The figure below illustrates the flow and relationship of the import risk analysis components.
Import risk analysis should be conducted in a transparent, systematic and unbiased manner. Transparency, in the context of import risk analysis, means the information and data gathered, the methods and assumptions used and the findings and conclusions made are clearly communicated to the exporting country and interested parties to explain the reason(s) for the import requirements or refusal to import. The methodology should be applied in a consistent and non-discriminatory manner for each exporting country. This means that the importing country must ensure that risks are evaluated equitably for all trade partners, regardless of the country of origin. If the risk posed by an exporting country is acceptable to an importing country, the same risk from any other country should also be acceptable to that importing country. In this next section, we will review the four components of risk analysis: hazard identification, risk assessment, risk management and risk communication.
In animal health import risk analysis, the hazard is the disease agent or pathogen of concern that is associated with the imported commodity. The definition provided in the terrestrial code states a hazard is a biological, chemical or physical agent in, or a condition of, an animal or animal product with the potential to cause an adverse health effect. The hazard(s) should be identified prior to engaging in the other risk analysis components.
Hazard identification is primarily a categorization step to determine which hazards are present in the trade regions and whether the hazard is present in the animal commodities under consideration for trade. The OIE-listed diseases, infections and infestations that affect cattle, sheep and goats should be considered. The animal commodities that may be traded; the animal disease status of the exporting country; the animal disease status of the importing country; and the importing country’s import regulations for animal health will determine the identification of relevant hazards for the import risk analysis.
Understanding the epidemiology of the hazard(s) can help to answer important questions for the risk assessment, including:
- What is the global distribution of the hazard?
- Is the hazard present in the commodities intended to be imported?
- How is the hazard transmitted? Are vectors or wildlife species involved in transmission?
- How is the hazard diagnosed?
- How is the hazard prevented?
After the identification of the hazard(s), the next component of import risk analysis is risk assessment. Risk assessment is the evaluation of the likelihood and the biological and economic consequences of entry, establishment and spread of a hazard.
There are several important principles to remember about risk assessments. First, risk assessments should be based on current, scientific information and supported with references from published literature or other primary sources. Second, they should follow a consistent, transparent method which allows flexibility to evaluate a variety of commodities, hazards and real-life scenarios. Third, risk assessments should state uncertainties, limitations and assumptions made and how these affect the conclusions of the risk assessment. Finally, risk assessments should be revisited and amended when new information becomes available.
There are four steps in risk assessment:
- Entry assessment.
- Exposure assessment.
- Consequence assessment.
- Risk estimation.
The steps are interrelated and conducted in sequential order. The entry and exposure assessments, when considered together, indicate the likelihood of the hazard(s) entering the importing country and spreading to animals within the importing country. This would be an outbreak disease event. The likelihood of an outbreak in combination with the consequence assessment provides the overall measure of risk from the hazard(s) from the beginning to end of the trade activities.
Risk management can be defined as the process of deciding upon and implementing measures to address the risks identified in the risk assessment, whilst at the same time ensuring that negative effects on trade are minimized. The primary players in risk management are the risk assessors and the risk managers in the importing country. Remember, according to the SPS Agreement, every country has the right to establish their own appropriate level of protection (ALOP). This risk level is different for every country, but cannot be zero.
The importing country must balance its objectives to minimize import risk(s) and protect its own animal health while applying the least restrictive trade requirements and fulfilling its obligations with the SPS Agreement and OIE membership.
There are four main components to the risk management process:
- Risk evaluation: compares the risk estimation from the risk assessment to the importing country’s ALOP.
- Option evaluation: the process of identifying, evaluating and selecting effective sanitary measures to bring the level of risk into alignment with the importing country’s ALOP.
- Implementation: the process of implementing the selected sanitary measure(s) and ensuring the import requirements can be effectively met.
- Monitoring and review: the ongoing process of periodically conducting audits or inspections to ensure the import requirements are achieving their intended purpose.
Risk communication is the process by which information and opinions regarding hazards and risks are gathered from potentially affected and interested parties during a risk analysis, and by which the results of the risk assessment and proposed risk management measures are communicated to the decision-makers and interested parties in the importing and exporting countries. Risk communication is not a finite step; rather, it is an ongoing, iterative (two-way) process among multiple participants that begins at the start of the import risk analysis and continues throughout the process.
The participants in risk communication are varied and dynamic, changing as the risk analysis process progresses and different needs arise. A risk communication strategy should be considered at the onset of the risk analysis to ensure information is openly and transparently shared among participants. The ultimate goal of risk communication is to reduce trade disputes amongst trading partners while implementing the least restrictive import requirement(s) needed to reach the importing country’s ALOP.
With import risk analysis, the best outcome is the one that reduces import risk to an acceptable level, while minimizing trade disputes, disagreements and import restrictions (non-tariff trade barriers) to effectively safeguard the animal health of the importing country. While disagreements and disputes can't always be entirely avoided, leveraging risk communication statements promotes an inclusive rather than exclusive approach. Thus, when stakeholders on both sides are involved in the process from the outset, they are less likely to challenge the outcomes, especially if their concerns can be adequately addressed.
Want to learn more about the concept of animal health?
Check out our free, self-paced, online Animal Health Learning Module, which explores the evolution of the United States' surveillance process, the value of a modern surveillance system and emergency response process, international trade and animal health, import risk analysis, risk management and risk communication, emergency preparedness and response, and concludes with a case study that allows learners to walk through a fictional country’s response to an African swine fever outbreak. Visit http://www.spscourses.com today to sign up for a free account and access this module and so much more!